U.S. patent number 11,389,580 [Application Number 16/273,459] was granted by the patent office on 2022-07-19 for dual chamber blood reservoir.
This patent grant is currently assigned to Sorin Group Italia S.r.l.. The grantee listed for this patent is Sorin Group Italia S.r.l.. Invention is credited to Claudio Silvestri, Gabriele Tommasi.
United States Patent |
11,389,580 |
Silvestri , et al. |
July 19, 2022 |
Dual chamber blood reservoir
Abstract
A blood reservoir may be used in combination with other elements
such as a heart lung machine (HLM), oxygenator, heat exchanger,
arterial filter and the like to form an extracorporeal blood
circuit that may be employed in a procedure such as a bypass
procedure. The blood reservoir may be configured to receive, filter
and store blood from a number of sources including vent blood (from
within the heart), venous blood (from a major vein), purge blood
(from a sampling line) and cardiotomy or suction blood (from the
surgical field).
Inventors: |
Silvestri; Claudio (Quarantoli
Mirandola, IT), Tommasi; Gabriele (Cavezzo,
IT) |
Applicant: |
Name |
City |
State |
Country |
Type |
Sorin Group Italia S.r.l. |
Milan |
N/A |
IT |
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Assignee: |
Sorin Group Italia S.r.l.
(Milan, IT)
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Family
ID: |
1000006442587 |
Appl.
No.: |
16/273,459 |
Filed: |
February 12, 2019 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20190167886 A1 |
Jun 6, 2019 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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14668933 |
Mar 25, 2015 |
10213541 |
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13181688 |
Apr 21, 2015 |
9011769 |
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Foreign Application Priority Data
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Jul 12, 2011 [EP] |
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11173655 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M
1/3666 (20130101); A61M 1/3632 (20140204); A61M
1/1698 (20130101); A61M 1/3638 (20140204); A61M
1/3627 (20130101); A61M 2202/0413 (20130101); A61M
2205/75 (20130101) |
Current International
Class: |
A61M
1/36 (20060101); A61M 1/16 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
86103696 |
|
Jan 1987 |
|
CN |
|
1147964 |
|
Apr 1997 |
|
CN |
|
1197677 |
|
Nov 1998 |
|
CN |
|
1458851 |
|
Nov 2003 |
|
CN |
|
2455229 |
|
May 1976 |
|
DE |
|
2754894 |
|
Jun 1979 |
|
DE |
|
3935502 |
|
May 1991 |
|
DE |
|
19840399 |
|
Mar 1999 |
|
DE |
|
102004040441 |
|
Jun 2006 |
|
DE |
|
102005001779 |
|
Sep 2006 |
|
DE |
|
102005029682 |
|
Dec 2006 |
|
DE |
|
102007026010 |
|
Nov 2010 |
|
DE |
|
0371173 |
|
Jun 1990 |
|
EP |
|
0587251 |
|
Mar 1994 |
|
EP |
|
0472480 |
|
Aug 1995 |
|
EP |
|
0820775 |
|
Jan 1998 |
|
EP |
|
0952433 |
|
Oct 1999 |
|
EP |
|
1053760 |
|
Nov 2000 |
|
EP |
|
1070509 |
|
Jan 2001 |
|
EP |
|
0690730 |
|
May 2002 |
|
EP |
|
1210956 |
|
Jun 2002 |
|
EP |
|
1003575 |
|
Oct 2004 |
|
EP |
|
0766974 |
|
Sep 2006 |
|
EP |
|
2754458 |
|
Jul 2014 |
|
EP |
|
2435106 |
|
Nov 2014 |
|
EP |
|
2842584 |
|
Mar 2015 |
|
EP |
|
2811752 |
|
Jan 2002 |
|
FR |
|
2009862 |
|
Jun 1979 |
|
GB |
|
2109934 |
|
Jun 1983 |
|
GB |
|
56-023960 |
|
Mar 1981 |
|
JP |
|
57-500411 |
|
Mar 1982 |
|
JP |
|
62-258671 |
|
Nov 1987 |
|
JP |
|
03-091352 |
|
Sep 1991 |
|
JP |
|
08-019602 |
|
Jan 1996 |
|
JP |
|
08-506982 |
|
Jul 1996 |
|
JP |
|
11-506701 |
|
Jun 1999 |
|
JP |
|
2944749 |
|
Sep 1999 |
|
JP |
|
2000-000299 |
|
Jan 2000 |
|
JP |
|
2001-503665 |
|
Mar 2001 |
|
JP |
|
2001-204815 |
|
Jul 2001 |
|
JP |
|
2001-514939 |
|
Sep 2001 |
|
JP |
|
2001-523339 |
|
Nov 2001 |
|
JP |
|
2002-165878 |
|
Jun 2002 |
|
JP |
|
2002-336348 |
|
Nov 2002 |
|
JP |
|
2003-052717 |
|
Feb 2003 |
|
JP |
|
2003-126246 |
|
May 2003 |
|
JP |
|
2005-066013 |
|
Mar 2005 |
|
JP |
|
2006-025531 |
|
Jan 2006 |
|
JP |
|
2006-325750 |
|
Dec 2006 |
|
JP |
|
2007-130290 |
|
May 2007 |
|
JP |
|
2008-000597 |
|
Jan 2008 |
|
JP |
|
2008-194386 |
|
Aug 2008 |
|
JP |
|
2008-270595 |
|
Nov 2008 |
|
JP |
|
2009-240428 |
|
Oct 2009 |
|
JP |
|
2009-287593 |
|
Dec 2009 |
|
JP |
|
2011-076394 |
|
Apr 2011 |
|
JP |
|
94/21311 |
|
Sep 1994 |
|
WO |
|
96/24397 |
|
Aug 1996 |
|
WO |
|
97/33672 |
|
Sep 1997 |
|
WO |
|
98/20957 |
|
May 1998 |
|
WO |
|
98/48868 |
|
Nov 1998 |
|
WO |
|
99/08734 |
|
Feb 1999 |
|
WO |
|
99/65413 |
|
Dec 1999 |
|
WO |
|
00/15154 |
|
Mar 2000 |
|
WO |
|
00/44415 |
|
Aug 2000 |
|
WO |
|
01/47442 |
|
Jul 2001 |
|
WO |
|
01/76656 |
|
Oct 2001 |
|
WO |
|
02/39931 |
|
May 2002 |
|
WO |
|
02/39933 |
|
May 2002 |
|
WO |
|
02/95675 |
|
Nov 2002 |
|
WO |
|
03/26724 |
|
Apr 2003 |
|
WO |
|
2006/021295 |
|
Mar 2006 |
|
WO |
|
2006/057650 |
|
Jun 2006 |
|
WO |
|
2006/122282 |
|
Nov 2006 |
|
WO |
|
2007/018513 |
|
Feb 2007 |
|
WO |
|
2008/119993 |
|
Oct 2008 |
|
WO |
|
2009/144522 |
|
Dec 2009 |
|
WO |
|
2010/041604 |
|
Apr 2010 |
|
WO |
|
2014/041604 |
|
Mar 2014 |
|
WO |
|
Other References
Catalog of Products, 2009 Terumo Europe Cardiovascular Systems, 142
pages. cited by applicant .
Definition of "Cylinder", downloaded from
http://dictionary.reference.com/browse/cylinder, download on Apr.
28, 2014, 3 pages. cited by applicant .
European Search Report and Search Opinion Received for EP
Application No. 14164506.9, dated Sep. 19, 2014, 10 pages. cited by
applicant .
European Search Report issued in EP Application No. 11173655,
completed Nov. 30, 2011, 9 pages. cited by applicant .
Extended European Search Report issued in 14188440.3, dated Jan.
30, 2015, 7 pages. cited by applicant .
Fischer, Gerhard, Betriebsmesstechnik, unveranderte Auflage, VEB
Verlag Technik Berlin, 1986, 3 pages (machine translations:
Business measuring technique, unchanged edition). cited by
applicant .
Henriksen Kerm et al., "Envisioning Patient Safety in the Year
2025: Eight Perspectives", Advances in Patient Safety: New
Directions and Alternative Approaches, Agency for Healthcare
Research and Quality, vol. 1, Aug. 2008. cited by applicant .
International Preliminary Report on Patentability issued in
PCT/IB2014/061491 dated Dec. 1, 2016, 12 pages. cited by applicant
.
International Preliminary Report on Patentability received for PCT
Patent Application No. PCT/IB2011/051639, dated Nov. 1, 2012, 10
pages. cited by applicant .
International Preliminary Report on Patentability received for PCT
Patent Application No. PCT/IB2012/053497, dated Jan. 23, 2014, 10
pages. cited by applicant .
International Preliminary Report on Patentability, Chapter II,
issued in PCT/EP2010/055522, (with translation) dated May 31, 2011,
13 pages. cited by applicant .
International Search Report and Written Opinion issued in
PCT/EP2010/055522, (with translation) dated Aug. 6, 2010, 10 pages.
cited by applicant .
International Search Report and Written Opinion issued in
PCT/IB2011/051639, dated Nov. 18, 2011, 15 pages. cited by
applicant .
International Search Report and Written Opinion issued in
PCT/IB2014/061491, dated Mar. 6, 2015, 16 pages. cited by applicant
.
International Search Report and Written Opinion received for PCT
Patent Application No. PCT/IB2012/053497, dated Nov. 15, 2012, 12
pages. cited by applicant .
Klonoff, David C., "Designing an Artificial Pancreas System to be
Compatible with Other Medical Devices", Journal of Diabetes Science
and Technology, vol. 2, No. 5, Sep. 2008, pp. 741-745. cited by
applicant .
Terumo Europe Cardiovascular Systems, Innovative Products for the
Treatment of Cardiovascular Disease, 2006 Terumo Europe, 105 pages.
cited by applicant .
Van der Togt, Remko et al., "Electromagnetic Interference From
Radio Frequency Identification Inducing Potentially Hazardous
Incidents in Critical Care medical Equipment", JAMA, Jun. 25, 2008,
vol. 299, No. 24, 7 pages. cited by applicant .
Weber, Tim, "Talking Barcodes that Change our Lives", BBC News,
published Apr. 48, 2004, 3 pages. cited by applicant .
Wikipedia, "Fullstandmessung" [online]. Retrieved from
https://de.wikipedia.org/w/index.php?title=F%C3%BCIIstandmessung&oldid=69-
-998631, last modifed Jan. 30, 2010. English translation retrieved
from https://en.wikipedia.org/wiki/Level_sensor, Oct. 18, 2016.
cited by applicant.
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Primary Examiner: Zimbouski; Ariana
Attorney, Agent or Firm: Seager, Tufte & Wickhem LLP
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATION
The application is a continuation of U.S. application Ser. No.
14/668,933 filed Mar. 25, 2015, which is a division of U.S.
application Ser. No. 13/181,688, filed Jul. 13, 2011, now U.S. Pat.
No. 9,011,769, issued Apr. 21, 2015, which claims priority to
European Patent Application 11173655.9, filed Jul. 12, 2011, all of
which are hereby incorporated by reference in their entirety.
Claims
The following is claimed:
1. An extracorporeal blood circuit comprising: a heart lung
machine; an oxygenator; a sampling line downstream of the
oxygenator; and a blood reservoir including a first vent blood
inlet, a venous blood inlet, a purgers port for accepting blood
from the sampling line, and a purgers funnel in fluid communication
with the purgers port, wherein the venous blood inlet extends
downwardly through an interior of the purgers funnel, the purgers
funnel being configured to permit the blood from the sampling line
to exit the purgers funnel and flow downwardly along an exterior
surface of the venous blood inlet; wherein the blood reservoir is
configured to accommodate blood from the sampling line and reducing
gaseous microembolic activity within the blood from the sampling
line.
2. The extracorporeal blood circuit of claim 1, further comprising
a defoamer disposed such that the purgers funnel extends through
the defoamer and at least part of the purgers funnel extends below
the defoamer.
3. The extracorporeal blood circuit of claim 1, wherein the purgers
funnel has an upper portion, a lower portion and an intervening
central portion, wherein the upper portion of the purgers funnel is
in fluid communication with the purgers port.
4. The extracorporeal blood circuit of claim 3, comprising a venous
tube in fluid communication with the venous blood inlet and
extending within the purgers funnel, such that the lower portion of
the purgers funnel is configured to extend alongside a portion of
the venous tube.
5. The extracorporeal blood circuit of claim 4, wherein the lower
portion of the purgers funnel has an inner diameter that is greater
than an outer diameter of the venous tube such that blood exiting
the purgers funnel slides down an exterior surface of the venous
tube.
6. The extracorporeal blood circuit of claim 5, comprising an
elongate filter disposed such that the venous tube extends
downwardly inside the elongate filter.
7. The extracorporeal blood circuit of claim 6, comprising a
reservoir housing and wherein the elongate filter extends to near a
lower surface of the reservoir housing.
8. The extracorporeal blood circuit of claim 3, comprising a first
vent tube in fluid communication with the first vent blood inlet
and extending external to the lower portion of the purgers funnel,
wherein the first vent tube extends downwardly within the upper
portion of the purgers funnel and passes to an exterior thereof
through a first aperture formed in the central portion of the
purgers funnel.
9. The extracorporeal blood circuit of claim 8, comprising a second
vent blood inlet and a second vent tube in fluid communication with
the second vent blood inlet and extending external to the lower
portion of the purgers funnel, wherein the second vent tube extends
downwardly within the upper portion of the purgers funnel and
passes to an exterior thereof through a second aperture formed in
the central portion of the purgers funnel.
10. An extracorporeal blood circuit comprising: a heart lung
machine; an oxygenator; a sampling line downstream of the
oxygenator; and a blood reservoir including: a vent blood inlet; a
venous blood inlet; a purgers port for accepting blood from the
sampling line; a purgers funnel having an upper portion, a lower
portion and an intervening central portion, the upper portion in
fluid communication with the purgers port; and a defoamer situated
so the purgers funnel extends through the defoamer and at least
part of the lower portion of the purgers funnel extends below the
defoamer.
11. The extracorporeal blood circuit of claim 10, wherein the
venous blood inlet extends downwardly through an interior of the
purgers funnel and the purgers funnel is configured to permit the
blood from the sampling line to flow downwardly along an exterior
surface of the venous blood inlet.
12. The extracorporeal blood circuit of claim 10, comprising a
releasable barrier, wherein the blood reservoir includes an
activated section and a non-activated section, and the releasable
barrier is situated between the activated section and the
non-activated section and configured to be released to permit blood
within the activated section to enter the non-activated section in
a situation requiring additional blood.
13. The extracorporeal blood circuit of claim 12, wherein the
non-activated section comprises an elongate filter.
14. The extracorporeal blood circuit of claim 12, comprising a
porous media disposed to dissipate velocity of blood flowing from
the activated section to the non-activated section.
Description
TECHNICAL FIELD
The present invention relates generally to blood reservoirs for
oxygenators used in blood perfusion systems.
BACKGROUND
Blood perfusion involves encouraging blood through the vessels of
the body. For such purposes, blood perfusion systems typically
include the use of one or more pumps in an extracorporeal circuit
that is interconnected with the vascular system of a patient. Many
surgical procedures require or prefer temporary cessation of the
heart to create a still operating field. Such procedures may thus
rely upon a cardiopulmonary bypass (CPB) perfusion system that
temporarily replaces the function of the heart and lungs. Examples
of such procedures include the surgical correction of vascular
stenosis, valvular disorders, and congenital heart defects. In
perfusion systems used for cardiopulmonary bypass surgery, an
extracorporeal blood circuit is established that includes at least
one pump and an oxygenation device to replace the functions of the
heart and lungs, respectively.
More specifically, in cardiopulmonary bypass procedures,
oxygen-poor blood (i.e., venous blood) is gravity-drained or
vacuum-suctioned from a large vein entering the heart or another
major vein in the body (e.g., femoral) and is transferred through a
venous line in the extracorporeal circuit. The venous blood is
pumped to an oxygenator that provides for oxygen transfer to the
blood. Oxygen may be introduced into the blood by, for example,
transfer across a membrane. Concurrently, carbon dioxide is removed
across the membrane. The oxygenated blood is filtered and then
returned through an arterial line to the aorta, femoral, or other
artery.
In many cases, an extracorporeal blood circuit includes a blood
reservoir that can be used to collect, filter and de-aerate blood
from a variety of different sources. For example, a blood reservoir
may receive one or more of venous blood from a large vein, vent
blood that is collected within the heart and cardiotomy or suction
blood that is collected from outside the heart but within the
surgical field.
SUMMARY
The present invention relates to a blood reservoir that may be used
in combination with other elements such as a heart lung machine
(HLM), oxygenator, heat exchanger, arterial filter and the like to
form an extracorporeal blood circuit. The blood reservoir, as will
be described in greater detail herein, may be configured to
receive, filter and store blood from a number of sources including
vent blood (from within the heart), venous blood (from a major
vein), purge blood (from a sampling line) and cardiotomy or suction
blood (from within the surgical field). Example 1 is a dual chamber
blood reservoir including an activated section and a non-activated
section. The non-activated, or clean, section includes an elongate
filter and a foamer that is disposed about an upper region of the
elongate filter. A purgers funnel extends downwardly through the
cylindrical foamer and includes a conical upper portion, a
cylindrical lower portion and an intervening central portion. A
venous inlet tube extends downwardly through the cylindrical lower
portion of the purgers funnel to a position that is proximate a
bottom surface of the elongate filter. A vent inlet tube extends
downwardly through an aperture formed within the central portion of
the purgers funnel to a position that is proximate the bottom
surface of the elongate filter.
In Example 2, the dual chamber blood reservoir of Example 1 in
which blood that exits the cylindrical lower portion of the purgers
funnel is able to slide down the exterior surface of the venous
inlet tube.
In Example 3, the dual chamber blood reservoir of Example 1 or 2 in
which the central portion of the purgers funnel includes a first
aperture that is configured to accommodate the vent inlet tube
passing therethrough.
In Example 4, the dual chamber blood reservoir of any of Examples
1, 2 or 3, further including a second vent inlet tube that extends
downwardly to a position that is proximate the bottom of the
elongate filter.
In Example 5, the dual chamber blood reservoir of Example 4,
wherein the central portion of the purgers funnel includes a second
aperture that is configured to accommodate the second vent inlet
tube, the first and second apertures being radially spaced apart
about 180 degrees.
In Example 6, the dual chamber blood reservoir of any of Examples 1
to 5, further including a plurality of purge ports that are in
fluid communication with the conical upper portion of the purgers
funnel.
In Example 7, the dual chamber blood reservoir of any of Examples 1
to 6 in which the activated section includes a suction blood filter
assembly including a cylindrical suction blood filter and a
defoamer layer that is disposed about the cylindrical suction blood
filter.
In Example 8, the dual chamber blood reservoir of any of Examples 1
to 7, further including a releasable barrier between the activated
section and the non-activated section, the releasably barrier
configured to be released to permit blood within the activated
section to enter the non-activated section in a situation requiring
additional blood.
In Example 9, the dual chamber blood reservoir of Example 8,
further including a porous media disposed to dissipate velocity in
blood flowing from the activated section to the non-activated
section.
Example 10 is a dual chamber blood reservoir having a housing and a
cover spanning the housing. A first vent port and a second vent
port each extend through the cover. A venous port extends through
the cover. A purgers port extends through the cover. The blood
reservoir includes a purgers funnel that has an upper portion, a
lower portion and an intervening central portion. The upper portion
is in fluid communication with the purgers port. A first vent tube
is in fluid communication with the first vent port and extends
externally to the lower portion of the purgers funnel to a position
near a lower surface of the housing. A second vent tube is in fluid
communication with the second vent port and extends externally to
the lower portion of the purgers funnel to a position near the
lower surface of the housing. A venous tube is in fluid
communication with the venous port and extends within the purgers
funnel to a position near the lower surface of the housing.
In Example 11, the dual chamber blood reservoir of Example 10 in
which the first vent tube extends downwardly within the upper
portion of the purgers funnel and passes to an exterior of the
purgers funnel through a first aperture formed in the central
portion of the purgers funnel.
In Example 12, the dual chamber blood reservoir of Example 10 or 11
in which the first vent tube extends downwardly within the upper
portion of the purgers funnel and passes to an exterior of the
purgers funnel through a first aperture formed in the central
portion of the purgers funnel.
In Example 13, the dual chamber blood reservoir of any of Examples
10 to 12, further including an elongate filter disposed within the
housing such that the vent tubes and the venous tube extend
downwardly through the elongate filter.
In Example 14, the dual chamber blood reservoir of Example 13 in
which the elongate filter has a lower surface that is disposed near
the lower surface of the housing.
In Example 15, the dual chamber blood reservoir of any of Examples
10 to 14, further including a plurality of purgers ports that pass
through the cover and that are in fluid communication the upper
portion of the purgers funnel.
Example 16 is a blood reservoir having a housing and a filtering
assembly disposed within the housing. The housing has a top, a
bottom, a venous inlet, a vent inlet and a purgers inlet. The
filtering assembly extends from near the top of the housing to near
the bottom of the housing. The filtering assembly includes a
support structure, a filter membrane disposed about the support
structure and a defoamer that is disposed about the filter
membrane. The filtering assembly includes a purgers funnel that is
in fluid communication with the purgers inlet and that extends
downwardly within the filter membrane. The filtering assembly
includes a venous tube that is in fluid communication with the
venous inlet and that extends through an interior of the purgers
funnel to a location near a bottom surface of the filtering
assembly. The filtering assembly also includes a vent tube that is
in fluid communication with the vent inlet and that extends
partially through an interior of the purgers funnel and partially
exterior to the purgers funnel to a location near the bottom
surface of the filtering assembly.
In Example 17, the blood reservoir of Example 16 in which the
venous tube and the vent tube extend downwardly within an interior
space of the filter membrane.
In Example 18, the blood reservoir of Example 16 or 17 in which the
purgers inlet includes a plurality of purgers ports.
Example 19 is an extracorporeal blood circuit that includes a heart
lung machine, an oxygenator, a sampling line downstream of the
oxygenator and a blood reservoir. The blood reservoir includes a
vent blood inlet, a venous blood inlet and a purgers port
configured to accept blood from the sampling line. The blood
reservoir is configured to accommodate blood from the sampling line
without causing excessive gaseous microembolic activity within the
blood from the sampling line.
In Example 20, the extracorporeal blood circuit of Example 19 in
which the blood reservoir includes a purgers funnel that is in
fluid communication with the purgers port, with the venous blood
inlet extending downwardly through an interior of the purgers
funnel such that blood from the sampling line is permitted to flow
downwardly along an exterior surface of the venous blood inlet.
While multiple embodiments are disclosed, still other embodiments
of the present invention will become apparent to those skilled in
the art from the following detailed description, which shows and
describes illustrative embodiments of the invention. Accordingly,
the drawings and detailed description are to be regarded as
illustrative in nature and not restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic illustration of an extracorporeal blood
circuit in accordance with an embodiment of the present
invention.
FIG. 2 is a partially cross-sectioned perspective view of a blood
reservoir in accordance with an embodiment of the present
invention.
FIG. 3A is a cross-sectional view of the blood reservoir of FIG.
2.
FIG. 3B is a partially cross-sectioned perspective view of a blood
reservoir in accordance with an embodiment of the present
invention.
FIG. 3C is a cross-sectional view of the blood reservoir of FIG.
3B.
FIG. 4 is a perspective view of a purgers funnel in accordance with
an embodiment of the present invention.
FIG. 5 is a perspective view of a filtering assembly in accordance
with an embodiment of the present invention.
FIG. 6 is a cross-sectional view of the filtering assembly of FIG.
5.
FIG. 7 is a perspective view of a portion of the filtering assembly
of FIG. 5.
FIG. 8 is a perspective view of a filtering assembly in accordance
with an embodiment of the present invention.
DETAILED DESCRIPTION
FIG. 1 is a schematic illustration of an extracorporeal blood
circuit 10. As illustrated, the extracorporeal blood circuit 10
includes an HLM 12, an oxygenator 14, a sampling device 16 and a
blood reservoir 18. The HLM 12 is in fluid communication with a
patient 20 and as such can receive blood from the patient 20 and
moreover can return blood and other fluids to the patient 20. The
sampling device 16 may be a port or similar structure that permits
blood to be withdrawn from the extracorporeal blood circuit 10 for
lab work and/or additional testing done in the surgical arena.
Blood in the sampling device 16 may flow into the blood reservoir
18 through a sampling line 22.
FIG. 2 is a partially cross-sectioned perspective view of a blood
reservoir 24 that may be used as the blood reservoir 18 in the
extracorporeal blood circuit 10 of FIG. 1. The blood reservoir 24
includes a clean (i.e., non-activated) section 26 and a dirty
(i.e., activated) section 28. In this, "clean" and "dirty" are
relative terms pertaining to an expected level of solid particles
or air bubbles within the blood entering each section. For example,
vent blood and venous blood, which are usually fairly clean, may be
processed within the non-activated section 26, while suction blood,
which tends to contain relatively more debris, may be processed
within the activated section 28.
As shown in FIG. 2, the blood reservoir 24 includes a housing 30
and a cover 32. A number of blood inlets, as will be described,
extend through or are otherwise disposed within the cover 32. The
housing 30 includes a blood outlet 34 that may, in some
embodiments, be in fluid communication with the HLM 12. The housing
30 tapers to a bottom 46. The cover 32 accommodates a venous inlet
port 36, one or more vent inlet ports 38 (only one is visible in
this view) and a purgers inlet 40 having one or more purgers ports
42. The cover 32 also accommodates a suction inlet 44. In some
embodiments, one or more of the venous inlet port 36, the vent
inlet port(s) 38, the purgers inlet 40 or the suction inlet 44 may
pass through the cover 32 such that they can rotate relative to the
cover 32.
As shown, the non-activated section 26 includes a filtering
assembly 48, while the activated section 28 includes a
filtering/defoaming assembly 50. FIG. 3A is a cross-sectional view
taken along line 3-3 of FIG. 2 and provides greater detail
pertaining to the filtering assembly 48 and the filtering/defoaming
assembly 50. The blood reservoir 24 includes a movable or
releasable valve 52 that, when in place as illustrated, keeps blood
within the activated section 28 from entering the non-activated
section 26. In some cases, there may be a need for more blood than
is available from the non-activated section 26 and thus the valve
52 may be lifted, rotated or otherwise moved to permit blood to
pass from the activated section 28 to the non-activated section
26.
In some embodiments, the housing 30 may include a shield 54 that
directs blood from the activated section 28 towards the bottom 46.
The shield 54 may be shaped and positioned to minimize turbulence
within the blood flow. While relative blood levels may vary during
use in the non-activated section 26 and the activated section 28
(when the valve 52 is closed), in some embodiments, the blood level
within the non-activated section 26, indicated by a line 56, may be
relatively lower than the blood level within the activated section
28, as indicated by a line 58. In some embodiments, the blood level
within the non-activated section 26 may instead be higher than the
blood level within the activated section 28.
In the activated section 28, the suction filtering/defoaming
assembly 50 includes several components. Blood from the suction
inlet 44 may pass into a collection funnel 60 and may then slide or
otherwise flow down a diverter 62 that is configured to minimize
turbulence in the blood flow. The blood then passes through a
cylindrical filter 64 and a defoamer 66 that is disposed about the
cylindrical filter 64. Blood thus filtered then collects within the
activated section 28, where it is stored until it is either needed
or subsequently discarded through an exit port 68.
In the non-activated section 26, the filtering assembly 48 includes
several components, not all of which are visible in FIG. 3A. The
filtering assembly 48 includes an elongate cylindrical filter 70
having a lower surface 72. A venous inlet tube 74 that is in fluid
communication with the venous inlet port 36 extends downwardly
through an interior of the elongate cylindrical filter 70 and
terminates at a position that is near the lower surface 72 of the
elongate cylindrical filter 70. A cylindrical defoamer 76 is
disposed about an upper region of the elongate cylindrical filter
70.
The filtering assembly 48 also includes a purgers funnel 78 that
extends downwardly through the cylindrical defoamer 76 and into the
elongate cylindrical filter 70. The purgers funnel 78 is in fluid
communication with the purgers inlet 40. The venous inlet tube 74
extends downwardly through the purgers funnel 78. In some
embodiments, the venous inlet tube 74 has an outer diameter that is
less than an inner diameter of the purgers funnel 78 such that
purgers blood collected within the purgers funnel 78 may exit the
purgers funnel 78 by sliding down an exterior of the venous inlet
tube 74. In some embodiments, this reduces turbulence in the flow
of purgers blood, thereby reducing or even eliminating the
formation of gaseous microembolic activity in the purgers blood. In
some embodiments, the purgers funnel 78 may include fingers (not
shown) that form an interference fit with the exterior of the
venous inlet tube 74 yet permit blood to flow down the exterior of
the venous inlet tube 74. In some embodiments, any entrained air
within the blood in the non-activated section 26 may travel up into
the cylindrical defoamer 76.
FIG. 3B is a partially cross-sectioned perspective view blood
reservoir 25 that may be used as the blood reservoir 18 in the
extracorporeal blood circuit 10 of FIG. 1. In some embodiments, the
blood reservoir 25 is similar in at least some constructional
aspects to the blood reservoir 24, and thus similar elements share
reference numbers therebetween. The blood reservoir 25 includes a
clean (i.e., non-activated) section 26 and a dirty (i.e.,
activated) section 28. In this, "clean" and "dirty" are relative
terms pertaining to an expected level of solid particles or air
bubbles within the blood entering each section. For example, vent
blood and venous blood, which are usually fairly clean, may be
processed within the non-activated section 26, while suction blood,
which tends to contain relatively more debris, may be processed
within the activated section 28.
As shown in FIG. 3B, the blood reservoir 25 includes a housing 30
and a cover 32. A number of blood inlets, as will be described,
extend through or are otherwise disposed within the cover 32. The
housing 30 includes a blood outlet 34 that may, in some
embodiments, be in fluid communication with the HLM 12. The housing
30 tapers to a bottom 46. The cover 32 accommodates a venous inlet
port 36, one or more vent inlet ports 38 (only one is visible in
this view) and a purgers inlet 40 having one or more purgers ports
42. The cover 32 also accommodates a suction inlet 44. In some
embodiments, one or more of the venous inlet port 36, the vent
inlet port(s) 38, the purgers inlet 40 or the suction inlet 44 may
pass through the cover 32 such that they can rotate relative to the
cover 32. As shown, the non-activated section 26 includes a
filtering assembly 48, while the activated section 28 includes a
filtering/defoaming assembly 50.
FIG. 3C is a cross-sectional view taken along line 3'-3' of FIG. 3B
and provides greater detail pertaining to the filtering assembly 48
and the filtering/defoaming assembly 50. The blood reservoir 25
includes a movable or releasable valve 52 that, when in place as
illustrated, keeps blood within the activated section 28 from
entering the non-activated section 26. In some cases, there may be
a need for more blood than is available from the non-activated
section 26 and thus the valve 52 may be lifted, rotated or
otherwise moved to permit blood to pass from the activated section
28 to the non-activated section 26.
In some embodiments, the housing 30 may include a shield 55 that
directs blood from the activated section 28 towards the bottom 46.
The shield 55 may be shaped and positioned to minimize turbulence
within the blood flow. In some embodiments, as illustrated, the
shield 55 may include a frame portion 57 and a porous media portion
59. The frame portion 57 supports the porous media portion 59 and
helps to anchor the shield 55 within the housing 30. The porous
media portion 59 slows blood passing through the shield 55.
While relative blood levels may vary during use in the
non-activated section 26 and the activated section 28 (when the
barrier 52 is closed), in some embodiments, the blood level within
the non-activated section 26, indicated by a line 56, may be
relatively lower than the blood level within the activated section
28, as indicated by a line 58. In some embodiments, the blood level
within the non-activated section 26 may instead be higher than the
blood level within the activated section 28.
In the activated section 28, the suction filtering/defoaming
assembly 50 includes several components. Blood from the suction
inlet 44 may pass into a collection funnel 60 and may then slide or
otherwise flow down a diverter 62 that is configured to minimize
turbulence in the blood flow. The blood then passes through a
cylindrical filter 64 and a defoamer 66 that is disposed about the
cylindrical filter 64. Blood thus filtered then collects within the
activated section 28, where it is stored until it is either needed
or subsequently discarded through an exit port 68. In some
embodiments, blood stored within the activated section 28 may be
released into the non-activated section 26 by opening the valve
52.
In the non-activated section 26, the filtering assembly 48 includes
several components, not all of which are visible in FIG. 3A. The
filtering assembly 48 includes an elongate cylindrical filter 70
having a lower surface 72. A venous inlet tube 74 that is in fluid
communication with the venous inlet port 36 extends downwardly
through an interior of the elongate cylindrical filter 70 and
terminates at a position that is near the lower surface 72 of the
elongate cylindrical filter 70. A cylindrical defoamer 76 is
disposed about an upper region of the elongate cylindrical filter
70.
The filtering assembly 48 also includes a purgers funnel 78 that
extends downwardly through the cylindrical defoamer 76 and into the
elongate cylindrical filter 70. The purgers funnel 78 is in fluid
communication with the purgers inlet 40. The venous inlet tube 74
extends downwardly through the purgers funnel 78. In some
embodiments, the venous inlet tube 74 has an outer diameter that is
less than an inner diameter of the purgers funnel 78 such that
purgers blood collected within the purgers funnel 78 may exit the
purgers funnel 78 by sliding down an exterior of the venous inlet
tube 74. In some embodiments, this reduces turbulence in the flow
of purgers blood, thereby reducing or even eliminating the
formation of gaseous microembolic activity in the purgers blood. In
some embodiments, the purgers funnel 78 may include fingers (not
shown) that form an interference fit with the exterior of the
venous inlet tube 74 yet permit blood to flow down the exterior of
the venous inlet tube 74. In some embodiments, any entrained air
within the blood in the non-activated section 26 may travel up into
the cylindrical defoamer 76.
FIG. 4 is a perspective view of an embodiment of the purgers funnel
78. In the illustrated embodiment, the purgers funnel 78 includes
an upper portion 80, a lower portion 82 and a tapered central
portion 84 between the upper portion 80 and the lower portion 82.
In some embodiments, the upper portion 80 may be conical or
otherwise tapered in shape. In some cases, the lower portion 82 may
be cylindrical in shape. In the illustrated embodiment, the central
portion 84 of the purgers funnel 78 includes a first aperture 86
and a second aperture 88. The first aperture 86 and the second
aperture 88 may be configured to permit first and second vent tubes
(illustrated in a subsequent Figure) to pass therethrough. In some
embodiments, the first aperture 86 and the second aperture 88 may
be radially spaced about 180 degrees apart.
FIG. 5 is a perspective view of the filtering assembly 48. The
filtering assembly 48 includes, as shown in FIG. 3A, the elongate
cylindrical filter 70 and the cylindrical defoamer 76. The elongate
cylindrical filter 70 includes a filter membrane 90 and a support
structure 92. As illustrated, the filter membrane 90 is disposed
inside of the support structure 92. In some embodiments, the filter
membrane 90 may instead be disposed about the support structure 92.
The support structure 92 may provide sufficient support to the
filter membrane 90 to hold the filter membrane 90 in a desired
configuration against the fluid pressures to which the filter
membrane 90 may be exposed during operation of the blood reservoir
24.
FIG. 6 is a cross-sectional view taken along line 6-6 of FIG. 5 and
illustrates a blood flow path for purgers blood. As indicated by
arrows 94, purge blood may enter the blood reservoir 24 through the
purgers ports 42. The purgers blood then travels down through the
purgers funnel 78 as indicated by arrows 96, and exits through a
bottom 98 of the purgers funnel 78. As indicated by arrows 100, the
blood then slides or otherwise flows down the exterior surface of
the venous inlet tube 74.
FIG. 7 is a perspective view of a portion of the filtering assembly
48, illustrating the venous inlet tube 74, a first vent tube 102
and a second vent tube 104. The venous inlet tube 74, the first
vent tube 102 and the second vent tube 104 extend downwardly from
the cover 32 through an interior of the elongate cylindrical filter
70. As shown in FIG. 4, the first vent tube 102 may pass through
the first aperture 86 and the second vent tube 104 may pass through
the second aperture 88. The first vent tube 102 may be considered
as extending within the purgers funnel 78 above the first aperture
86 but exterior to the purgers funnel 78 below the first aperture
86. Similarly, the second vent tube 104 may be considered as
extending within the purgers funnel 78 above the second aperture 88
but exterior to the purgers funnel 78 below the second aperture 88.
In some embodiments, the venous inlet tube 74, the first vent tube
102 and the second vent tube 104 each extend downwardly to a
position that is proximate or near to the lower surface 72 of the
elongate cylindrical filter 70. As a result, in some embodiments,
turbulence and resulting blood cell damage may be reduced or
eliminated.
FIG. 8 is a perspective view of an embodiment of the
filtering/defoaming assembly 50. In some embodiments, the
filtering/defoaming assembly 50 includes a plastic frame 150 that
supports the filtering/defoaming assembly 50 and provides the
filtering/defoaming assembly 50 with an annular or ovoid shape. A
foam cylinder such as a polyurethane foam cylinder 152 is disposed
within the plastic frame 150 and at least partially defines an
internal sliding surface 154. An outer surface of the foam cylinder
152 is at least partially wrapped in a polyester felt 156. In some
embodiments, the polyester felt 156 has a pore size of about 40
microns.
Various modifications and additions can be made to the exemplary
embodiments discussed without departing from the scope of the
present invention. For example, while the embodiments described
above refer to particular features, the scope of this invention
also includes embodiments having different combinations of features
and embodiments that do not include all of the above described
features.
* * * * *
References